Are Cancer Patients Willing to Participate in Clinical Trials During the COVID-19 Pandemic?

Patients with and survivors of cancer are concerned about COVID-19 and, as a result, may be less willing to take part in clinical trials, according to a survey.

“The coronavirus disease 2019 (COVID-19) outbreak substantially reduced cancer clinical trial accrual. Many sites temporarily paused enrollment owing to state, local, sponsor, or institutional restrictions intended to prevent the spread of COVID-19,” the study authors explained. “Once site and enrollment restrictions lift, it is unclear whether patients will be as willing to participate in clinical research as before the outbreak, especially if community COVID-19 transmission is still occurring.”

To glean the opinions of this population, the researchers recruited participants from the  American Cancer Society Cancer Action Network’s Survivor Views panel who were aged 18 years or older and had been diagnosed with and/or treated for cancer during the last five years. Survey questions for this study were related to COVID-19 and discussed “disposition toward trials, willingness to participate, and reasons for nonparticipation,” the researchers described.

Of 3,054 potential participants who received the survey, 933 responded, for a 30.6% response rate. Of the 924 with known data on sex, 675 (73.1%) were female; of the 920 with known data on race, 33 (3.6%) were Black; and of the 924 with known annual household income data, 284 (36.6%) had an income of $60,000 or less.

About a third of the entire cohort (n=316, 33.9%) said they had previously discussed clinical trials with their physician. About a fifth of patients (n=192, 20.6%) were extended an invitation to participate in a clinical trial, most of whom said yes (n=150, 78.1%) and eventually enrolled (n=116, 60.4%), making the overall participation rate 12.4%. Most of the remaining 662 participants who were not extended the invitation to participate (n=519, 78.4%) said they were somewhat or very likely to accept the offer if they were offered.

Participants were also asked if, in light of the pandemic, they were more or less likely, or if it made no difference, to take part in a clinical trial; 907 participants responded to this, most of whom (n=721, 79.5%) said it made no difference, while the rest “were more than 7 times more likely to indicate that the pandemic made them less likely to enroll in a clinical trial (164 [18.1%] vs 22 [2.4%]),” the study authors reported. The top two reasons given by those who said the pandemic would make them less likely to enroll were fear of increased COVID-19 exposure (70.1%) and difficulty accessing care during the pandemic (18.3%).

The results were published in JAMA Oncology.

“The National Cancer Institute and the US Food and Drug Administration have provided guidance on increasing flexibility for trial investigators during the COVID-19 pandemic. These guidelines focus on reducing COVID-19 exposure or offering alternative care settings. Trial sponsors will need to take full advantage of the approaches indicated in these guidelines to better address patient fears about clinical trial participation while the COVID-19 pandemic endures,” the researchers concluded.